Clinical Research Associate - Data & Site Monitoring Expert

CIARA O'DRISCOLL

Boston, MA 781-***-**** ***************@*****.***

Summary

Clinical Research Associate with over three years of clinical research. Current therapeutic focuses include aesthetics and spine & orthopedics. Research responsibilities have become more in depth through the years as responsibilities were added with new role but others carried over. Excellent computer literacy and quick to learn new programs and resources. Enjoys utilizing communication techniques while monitoring clinical sites remotely with weekly outreach or in person during visits. High attention to detail reconciling Investigation Product and vendor management. Enjoys being on a team or working individually finding balance in many environments. Certified in Mediation, and Conflict Resolution gaining interpersonal skills such as active listening to settle disputes. Often switches between projects and continuously adapt while valuing deadlines and attention to detail.

Clinical Research Experience

Health Policy Associates, Inc. - Dedham, MA

Clinical Research Associate

January 2025- Present

• Design/update data collection forms (CRFs) and informed consent forms

• Assist sites in getting IRB approvals for trial

• Point of first contact when site has inquiries regarding trial/conduct of trial

• Performing site visits from initiation to close out

• Write visit reports and follow up with site on unresolved issues

• Review all AESIs SAEs to ensure that all necessary parties are notified

• Training new staff

• Assists with FDA audits

Clinical Trial Associate

Sep 2023 – January 2025

• Organizes study documents and materials

• Create CRFs and compile study binders

• Maintain multiple trackers across different studies

• Oversee data entry

• Communicates directly with sites

• Generate internal and external queries, facilitate their resolution

• Resolves administrative issues on behalf of the project manager

• Prep documents for site monitoring visits

• Create test data to test new applications

• Works with IT to test and validate databases, assist with CAD and the development of EDC systems, logging bugs

• Help compile documents for FDA submissions

• Maintain trial master files and ensure that information is current

• Participate in team meetings

• Travel to monitoring visits

• Invoicing

Clinical Team Assistant

Jul 2022- Sep 2023

• Establishes eTMF

• Promptly and accurately distributes clinical trial supplies and Investigational Product

• Tracks and manages shipment orders

• Assembles compiled documents to send to sites such as checklists and patient binders

• Assists in training new personnel while maintaining personal timeframes and work load

• Prepares and distribute correspondence/ site outreach

• Opens and closes queries in EDC closely working with data team to resolve checks

• Remotely SDV subject diaries

• Copy, scans and files clinical trial documents

• Participate in team meetings

• QC SAS outputs

Other Experience

MetroWest Mediation Services -Natick, MA

Local Consumer Program Assistant

Oct 2022- Aug 2023

• Finds resolutions for complaints made to the Massachusetts Attorney General's Office

• Conducts investigations into complaints

• Advocates for consumer rights

• Manages phone, email and mail correspondence

• Mediates between consumers and businesses

• Resolves disputed of possibly $1,000+

Education

UMass Boston

Sep 2023- May 2024

Conflict Resolution Graduate Certificate

Salem State University 2019

Bachelor's in Media and Communications

Concentration: Public Relations Minor: Travel and Tourism Skills

• Microsoft Office (on and offline)

• iMedNet EDC

• Mediation

• Montium eTMF

• CITI Training- 2022

o Good Clinical Practice Course

o CTA, CRA Regulatory GCP

o 1-GCP

o Information Privacy Security (JPS)

o I-Basic Course

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